# K972096: Bivalve Nasal Splint

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Jul 15, 1997 after 41 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Product No. 20-10650: named in the summary without a submission number
- (no number) Product No. 20-10655: named in the summary without a submission number
- (no number) Product No. 20-10660: named in the summary without a submission number
- (no number) Product No. 20-10665: named in the summary without a submission number

## Most influential descendants
- K980221: Silimed Nasal Retainer (1998), 0 descendants of its own

## Indications for use
To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

Source page: https://510kreport.com/device/K972096
Methodology: https://510kreport.com/methodology